At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Systems **Job Category:** Professional **All Job Posting Locations:** Nijmegen, Netherlands **Job Description:** Are you ready for a new exciting opportunity as a **Quality Systems Analyst** in the Medical Device Sector? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands. This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do! In this role, you will play a crucial role in ensuring that our processes meet the highest standards of quality and compliance. You will have the opportunity to work with a team of exceptional professionals and contribute to the success of our goals. As Quality Systems Analyst you will report to the Quality Systems Lead and will act as the Change Control process owner and support the Internal and External Audit management process. In this position, you will drive the continuous education, implementation and improvement of Quality Systems and compliance with QS regulation and ISO within the GATT facility while ensuring that the site's Change Control process meet all business and regulatory requirements. Furthermore, as Quality Systems Analyst you will provide guidance to ensure compliance of process procedures with applicable regulations and standards, such as good manufacturing practices, good laboratory practices, quality system regulations, and organization of international standards, and will support the non conformance and CAPA processes, including administrative support to the Quality organization. **Responsibilities** + Acts as the Change Control process owner at the site and ensures adherence of the process at the site as well as acts as SME for this process during regulatory inspections + Ensures quality systems are effectively deployed and performs periodic checks to verify appropriate application. + Provides education/training as needed regarding Change Control. + Represents the site in the worldwide Change Control teams. + Conducts internal audits to verify compliance with quality management system standards as well as regulatory and customer requirements. + Assists with external audits, including preparation, execution and by generating reports with corrective action plans and ensuring implementation of corrective actions. + Supports tasks from Non conformance and CAPA processes + Uses statistical methods, quality tools and computer-generated reports to continuously improve process capability + Collaborate with Management and assists in the development of Quality Metrics to achieve company's Quality goals. + Leads and participates in quality systems improvement initiatives. + Identifies root causes of quality issues, develops corrective actions and recommendations, suggests process changes when appropriate. + Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business. + Backup on other tasks within QS department to assure business continuity, if required. **Experience, education and skills** + University / bachelor’s Degree or Equivalent. + 3-5 years work experience. + Medical device manufacturing experience preferred. + Able to communicate and writing skills in English. + Internal Auditor Qualification. Experience in conducting internal audits preferred. + Thorough understanding of medically regulated plant operations including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations preferred. + Ability to work independently and in teams and to communicate effectively with employees of various departments. + Ability to perform detail-oriented work and maintain accuracy, consistency and quality of documentation and projects. + Ability to function in a controlled manner regulated by FDA cGMPs & ISO standards, and handle confidential data. **Closing date:** Thursday 22nd of May.